Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD) (severally and collectively hereinafter referred to as “ADHD”) are developmental disorders, largely neurological disorders affecting 5% of the world population. The disorder typically presents itself during childhood, and is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility.
Inattentive behaviour is often characterized by difficulty focusing on one task, failure to pay attention to details, and making careless mistakes in a variety of tasks. Individuals exhibiting inattentive behavior may appear as if their minds are elsewhere or they are not listening or did not hear what has just been said.
Hyperactive people always seem to be in motion and may suffer from feelings of restlessness and difficulty engaging in sedentary activities. Common signs include excessive unproductive movement, excessive talking, and an inability to sit still. Hyperactive children often roam around the room, and feel compelled to touch everything.
Impatience and a failure to think before acting often characterize impulsivity. Impulsive young children may frequently interrupt others, fail to listen to directions, and have difficulty waiting for their turn.
These problems are reflected in impairment of a person's will or capacity to control his or her own behavior relative to the passage of time and to keep future goals and consequences in mind. ADHD is most commonly diagnosed in children and, over the past decade, has been increasingly diagnosed in adults. About 60% of children diagnosed with ADHD retain the disorder as adults.
Studies indicate that the disorder is highly heritable and that genetics contribute about three quarters of the total ADHD population. While the majority of ADHD is believed to be genetic in nature, ⅕ of all ADHD cases are thought to be acquired after conception due to brain injury caused by either toxins or physical trauma parentally or postnatally. Scientists have not yet identified a single underlying cause behind these behavior characteristics. While some have been linked to decreased brain activity, the biological reason for the decreased brain activity is still unknown. Treatment for ADD and ADHD is therefore limited to treating the symptoms of the disorders.
Methods of treatment usually involve some combination of medications, behaviour modifications, life style changes, and counseling.
The most common treatment for ADD and ADHD is the use of mild central nervous system stimulant drugs, such as Ritalin, Cylert, and Dexedrine. However, there are several drawbacks in using these drugs such as frequent short-term side effects include insomnia, loss of appetite, headaches, stomachaches, hyperactivity, drowsiness, blood pressure and pulse changes, and cardiac arrhythmia. In addition to this, the possible consequences of long-term exposure to these drugs in children are not thoroughly investigated. The use of Ritalin in children under six years of age is particularly undesirable since safety and efficacy in this age group has not been established.
As an alternative to the aforementioned conventional treatments, U.S. Pat. No. 5,719,178 discloses a method for treating ADHD comprising taking a quantity of proanthocyanidin sufficient to relieve symptoms of ADHD every 3.5 to 4.0 hours. A heterocyclic antidepressant, preferably desipramine may be taken optionally with the proanthocyanidin in quantities sufficient to attenuate ADHD-related symptoms of lack of cognitive focus. However, a major drawback of this method is that repeated doses are required to alleviate symptoms throughout the day, which is inconvenient as well as difficult especially for school going children.
U.S. Pat. No. 6,093,404 describes a therapeutic composition for treatment of ADD or ADHD comprising in percentage by weight: 3-9% proanthocyanidin, 30-40% yucca root, 15-25% hawthorn berry, 10-20% bilberry, 5-15% silymarin, and 10-15% gingko biloba.
U.S. Pat. No. 6,759,053 provides compositions and methods for using the S(+) enantiomer of desmethylselegiline (N-methyl-N-(prop-2-ynyl)-2-am-inophenylpropane), for the treatment of selegiline-responsive diseases and conditions. Diseases and conditions responsive to selegiline include those produced by neuronal degeneration or neuronal trauma and those due to immune system dysfunction. Effective dosages are a daily dose of at least about 0.015 mg/kg of body weight.
The use of 3-[1-[2-(1-acetyl-2,3-dihydro-1H-indol-3-yl)ethyl]-1,2, 3,6-tetr-ahydropyridin-4-yl]-6-chloro-1H-indole, any of its enantiomers and pharmaceutically acceptable salts thereof for the preparation of a pharmaceutical composition for the treatment of Attention Deficit Hyperactivity disorder is disclosed in US20040152737.
The pharmaceutical compositions are comprised of a therapeutically effective combination of a nicotine receptor partial agonist and an anti-ADHD agent and a pharmaceutically acceptable carrier and the method of using these compounds is disclosed in US20040220184
WO2003068251 describes herbal formulation comprising Bacopa monneri; Centella asiatica; Glcyrrhiza glabra; Withania somnifera and Celastrus paniculatus and process for preparing the same for treating Attention Deficiency Disorder in Humans. The herbs are subjected to solvent extraction using hazardous solvents such as hexane, chloroform, methanol and acetone. The herbs are extracted especially Brahmi and Jyotishmati using Hydrocarbon solvents such as Hexane, Chloroform which are considered hazardous to human health. The extraction of the herbs at higher temperature destroys or modifies molecular and chemical structure of temperature sensitive phytochemicals which may contribute to the therapeutic value of the herbs.
In a conventional solvent extraction process, the separation temperature is always greater than the extraction temperature. This means that when the solvent is recovered, the obtained extract is subjected to higher temperature, which is likely to destroy many temperature sensitive phyto nutrients and phyto chemicals in the extract.
A combination of hyperforin, 5-hydroxy triptophan, rhodiola rosea, along with Vitamins B, Vitamin C, Vitamin D3, and minerals like selenium and Zinc are sold under the brand name of Amoryn for treating ADHD disorders. The daily dose comprises 1 to 4 capsules per day.
There is a need in the art to provide herbal formulation for oral administration comprising safe and effective extracts of two or more herbs, effective for the treatment of ADHD, and is devoid of any side effects.